Clinical Trials

INCLUSION CRITERIA:

Eligibility Criteria for Initial Screening Phase of I-SPY 2 TRIAL

• Histologically confirmed cancer of the breast. 
• Clinically or radiologically measureable disease in the breast after diagnostic biopsy
• Prior therapy: No prior cytotoxic regimens are allowed for this malignancy. Participants may not have had prior chemotherapy, other targeted anticancer therapies, or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed.
• Age ≥ 18 years
• Women and men are eligible in this study
• Core biopsy: Willing and able to undergo core biopsy of the primary breast lesion to assess baseline biomarkers to determine eligibility for treatment phase of I-SPY 2 TRIAL.  
• Nonpregnant and non-breastfeeding
• No ferromagnetic prostheses

Inclusion Criteria for Treatment Phase of I-SPY 2 TRIAL

• Eligible breast tumors must also meet one of the following criteria:
  • Stage II or III;
  • T4, any N, M0, including clinical or pathologic inflammatory cancer;
  • Regional Stage III, where supraclavicular lymph nodes are the only sites of metastasis, will be evaluated at the time of surgery.
• Breast Receptor status: Any tumor ER/PgR status, any HER2/neu status as measured by local hospital pathology laboratory, and meets any tumor assay profile described in protocol. Tumors will be considered positive when:
  • ≥ 5% tumor staining for ER and/or PgR is seen;
  • Any one of the following these conditions for HER2 are met:
    •  IHC 3+
    • Overexpression by FISH
    • Amplification of HER2 as assessed by an acceptable alternative probe FISH.
• Normal organ and marrow function
• No uncontrolled or severe cardiac disease
• No clinical or imaging evidence of distant metastases by either:
  • Radiologic modalities (CT, PET/CT, PA and lateral CXR, or radionuclide bone scan); or
  • Laboratory levels of total bilirubin, ALT, and AST within normal range, assessed within 30 days of consenting to the treatment phase.
• Breast tumor assay profile must include one of the following:
  • MammaPrint High, any ER status, any HER2 status
  • MammaPrint Low, ER– (< 5%), any HER2 status
  • MammaPrint Low, ER+, HER2/neu positive by any one of the three methods used (IHC, FISH/alternative probe).

EXCLUSION CRITERIA:

• Use of any other investigational agents within 30 days of starting study treatment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent or accompanying supportive medications.
• Uncontrolled intercurrent illness 
• Sentinel lymph node dissection/biopsy on the nodes draining from the study index tumor site is not allowable prior to the start of chemotherapy. 
• Patient has a history of any invasive malignancy within 5 years prior to randomization. Exceptions include:
  • Breast Cancer
    • Patient with a history of invasive BC are eligible if diagnosed with TNBC or HER2+/HR- disease and no evidence of recurrence at least 5 years from diagnosis. Patient with HR+ invasive BC at any time are not eligible;
    • Prior DCIS is allowed if patient had definitive surgical resection and radiation as indicated per SOC and no evidence of HR+ micro-invasion.
  • Non-Breast Malignancies
    • History of carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin;
    • History of papillary thyroid cancer.